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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Manual Surgical Instrument
510(k) Number K844595
Device Name ORTHOPEDIC CUSTOM SURGICAL KIT
Applicant
Xanmed Corp.
815 Connecticut Ave. Nw
Washington,  DC  20006
Applicant Contact DAVID B VANCE
Correspondent
Xanmed Corp.
815 Connecticut Ave. Nw
Washington,  DC  20006
Correspondent Contact DAVID B VANCE
Regulation Number888.4540
Classification Product Code
LXH  
Date Received11/26/1984
Decision Date 08/21/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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